(196 days)
Not Found
No
The device description is for a simple, mechanical acupuncture needle and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "acupuncture therapy," which is a therapeutic practice.
No
The device, an acupuncture needle, is used for therapy (piercing the skin for acupuncture) and not for identifying or investigating a disease, disorder, or other condition.
No
The device description clearly states it is a physical acupuncture needle made of stainless steel and other materials, not software.
Based on the provided information, the Jiajian Acupuncture Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "piece the skin in the practice of acupuncture therapy." This is a direct therapeutic intervention on the patient's body.
- Device Description: The description details a physical needle used for insertion into the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the Jiajian Acupuncture Needle is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.
Product codes (comma separated list FDA assigned to the subject device)
MQX
Device Description
Jiajian brand Acupuncture Needle consists of a stainless steel wire (ASTM 304) as the needle body, with a stainless steel wire handle, a copper wire handle or polystyrol handle. The handles make the needles easier to manipulate and place.
The acupuncture needle is sterilized and disposable.
The diameter of the needle is 0.140.80mm; the length of the needle is 7100mm; the invasive length is 2~47mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified practitioners or acupuncture doctors
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.
0
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JIASVIAN 佳级医疗
Section 4
Premarket Notification [510(k)] Summary
[As required by CFR 21 807.92(c)]
AUG 1 1 2009
1 of 2
| Date: | July 10th, 2009 |
|---|---|
| Submitter: | Wuxi Jiajian Medical Instrument Co., Ltd |
| Qinghong Rd., Ehu Town, Xishan District, Wuxi, China 214116 | |
| Contactor: | Doris Dong |
| E-mail: autumn_cool@126.com | |
| Tel: 86 21 5834 2283 | |
| Fax: 86 21 5834 0486 | |
| US Agent: | Mark Thomas |
| E-mail: thomas_fda@yahoo.com | |
| Tel: 510-6522489 | |
| Fax: 510-6522460 | |
| Device Summary: | |
| Trade Name: | Jiajian Acupuncture Needle |
| Common or Usual Name: | Acupuncture needle |
| Classification Name: | needle, acupuncture, single use |
| Product Code: | MQX |
| Regulation Number: | 880.5580 |
| Medical Specialty: | General Hospital |
| Device Class: | II |
| Device Description: | Jiajian brand Acupuncture Needle consists of a stainless steel wire |
| (ASTM 304) as the needle body, with a stainless steel wire handle, a | |
| copper wire handle or polystyrol handle. The handles make the needles | |
| easier to manipulate and place. | |
| The acupuncture needle is sterilized and disposable. | |
| The diameter of the needle is 0.14~0.80mm; the length of the needle is | |
| 7 | |
| Indications for use: | Jiajian Acupuncture Needle is intended to piece the skin in the practice |
| of acupuncture therapy by qualified practitioners or acupuncture doctors | |
| as determined by the states. | |
| Sterilization: | Jiajian Acupuncture Needles are sterilized and manufactured in a clean |
| room meeting Standard ISO 14644-2. The devices are supplied sterile | |
| and are single use only. Do not attempt to resterilized product once the | |
| package has been opened. | |
| Sterilization method: The needles are sterilized by Co-60 irradiation at a | |
| validated dose level of 25kGy. The sterilization process is applied on | |
| finished devices following final packaging. The sterilization process is | |
| applied in accordance with Standards ISO 11137-1 by a qualified | |
| sterilizers from Accredited Sterilization Institue. | |
| Validation method used to validate sterilization cycle: The radiation | |
| dose level has been validated to get the sterility assurance level of $10^{-6}$ in | |
| 2 |
1
Wuxi Jiajian Medical Instrument Co., Ltd Qinghong Rd., Ehu Town, Xishan District, Wuxi, China Fax: 0510-88746629 URL: www.jiajian-healthcare.com Phone: 0510-88745788
accordance with Standard ISO 11737-1.
Substantial Equivalence Infomration:
| 1) Predicate Device: | |
|---|---|
| 510(k) Number: | K983800 |
| Marketing clearance date: | August 27th, 1999 |
| Product name: | DN Acupuncture Needles |
| Manufacturer: | Buckman Company, Inc. |
| 510(k) Number: | K974616 |
| Marketing clearance date: | February 5th, 1998 |
| Product name: | Singer Acupuncture Needles |
| Manufactuer: | Lorac, Inc. |
| 2) Comparison with predicate device | |
| Similarities: | 1) Similar materials composition and structure; |
| 2) Same intended use; | |
| 3) All are sterile; | |
| 4) All are used as prescription | |
| Differences: | 1) Different sizes scale |
、
- Conclusion: Jiajian Acupuncture Needle is substantially equivalent to acupuncture needles sold in the US market. It is SE to the following brand of acupuncture needles available in the US market: DN Acupuncture Needles (K983800) Singer Acupuncture Needles (K974616)
22
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2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Doris Dong Manager Wuxi Jiajian Medical Instrument Company, Limited Qinghong Rouad, Ehu Town, Xishan District Wuxi, Jiangsu 214116 CHINA
AUG 1 1 2009
Re: K090199
Trade/Device Name: Jiajian Acupuncture Needle Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: July 10, 2009 Received: July 28, 2009
Dear Ms. Dong:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2- Ms. Dong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony O. Anton
B.S., M.A.
Susan Runner, D.D.S., M.A Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Kogora
Section 3 Statement of Indications for Use
510(k) Number (if known): _K090199
Device Name: Jiajian Acupuncture Needle
Indications for Use:
Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)
Charles R. Bogle
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1 Updated July 10th, 2009
510(k) Number: K090199
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